Evaluation of Heart Rate Variability and Endothelial Function Three Months After Bariatric Surgery

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Procedure: Bariatric Surgery

• Registration Number: NCT03911479
• Lead Sponsor: Rio de Janeiro State University

Brief Summary

Was performed a longitudinal, study with twenty patients recruited for the bariatric surgery group and 20 for clinical treatment. The analysis of HRV and endothelial function were performed through peripheral arterial tonometry, in patients with obesity before and after three months of bariatric surgery. Were also analyzed GLP-1, insulin and glucose at fast, and 30 and 60 minutes. The results were compared in parallel with a control group with clinical treatment for obesity.

Detailed Description

To assess the pathophysiological mechanisms that leads the benefits in cardiovascular risk after bariatric surgery, through the autonomic nervous system and endothelial function, was performed a longitudinal, study with twenty patients recruited for the bariatric surgery group and 20 for clinical treatment.

The analysis of HRV and endothelial function were performed through peripheral arterial tonometry, in patients with obesity before and after three months of bariatric surgery.

Were also analyzed GLP-1, insulin and glucose at fast, and 30 and 60 minutes. The results were compared in parallel with a control group with clinical treatment for obesity.

Study Timeline

• Study Start: 2015-10-01
• Primary Completion: 2016-02-25
• Study Completion: 2018-02-22
• Status Verified: 2019-04
• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-10
• Last Update Submitted: 2019-04-10
• Study First Posted: 2019-04-11
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients with obesity grade 3 [Body Mass Index (BMI) ≥ 40kg/m2] or grade 2 (BMI 35-39.9kg/m2) with comorbidities

Exclusion Criteria

Current use of incretin mimetics or inhibitors of dipeptidyl peptidase-4 (DPP4); and history of a previous cardiovascular event (acute myocardial infarction, stroke or peripheral obstructive arterial disease)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bariatric Surgery Group	Bariatric Surgery	-
Clinical Threatment	Bariatric Surgery	Convencional treatment in a public tertiary outpatients care unit

Primary Outcome Measures

Name	Time	Method
Rate variability and endothelial function	3 months	assessed by peripheral arterial tonometry